Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

Drinking Excessive Clinical Trial

Official title:

Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649982
• Other study ID #: ALCOHOLDIARY2
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Martin Kraepelien, PhD
• Phone: +46703017500
• Email: martin.kraepelien[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the effects on alcohol consumption, and the consumption of time spent by a qualified clinician, by adding different forms of guidance to a digital intervention based on an alcohol diary and techniques from cognitive behavioral therapy and relapse prevention. The participants will be adults with problematic alcohol use. The trial will be a 2*2 factorial experiment where written guidance and/or an extra mid-treatment telephone interview will be added to the basic digital intervention, by randomization. The randomized factorial experiment will create four equally large groups (1:1:1:1) who will receive different combinations of added guidance. Main outcome will be effects on alcohol consumption. Effects on alcohol consumption will also be combined with clinician time spent on guidance to assess the resource-effectiveness of added forms of guidance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years of age

2. Access to internet

3. =8 points for men and =6 points for women on Alcohol Use Disorders Identification Test (AUDIT)

Exclusion Criteria:

1. Insufficient knowledge of the Swedish language

2. Difficulties reading or writing related to a digital intervention.

3. Other ongoing psychological treatment with a content similar to that in the current study (problematic alcohol use).

4. High suicide risk based on telephone assessment.

5. Other urgent need for more intensive psychiatric care, or addiction care services, based on telephone assessment.

Related Conditions & MeSH terms

• Alcohol Drinking
• Drinking Excessive

Intervention

Behavioral:
• ALVA
Behavioural digital self-help intervention

Locations

Country	Name	City	State
Sweden	Centre for Psychiatry Research	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinician time	Time in minutes the clinician spends on the participant giving guidance through telephone calls and/or written guidance, in minutes, lower is better.	Immediately after the intervention
Primary	Standardized drinks per week (based on Time Line Follow Back)	Changes in standardized drinks per week (using Time Line Follow Back)	Immediately after the intervention
Secondary	Standardized drinks per week (based on Time Line Follow Back)	Changes in standardized drinks per week (using Time Line Follow Back)	12 months after intervention
Secondary	Diagnostic criteria Alcohol Use Disorder	Using SCID-5, number of diagnostic criteria 0-11, lower is better	6 months after intervention
Secondary	Credibility/Expectancy questionnaire	Credibility/Expectancy questionnaire, score range 0-50, higher is better	Mid-intervention (4 weeks after intervention start)
Secondary	Alcohol Use Disorders Identification Test	Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better	12 months after intervention
Secondary	Brunnsviken Brief Quality of Life Scale	Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better	12 months after intervention
Secondary	Penn Alcohol Craving Scale	Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better	12 months after intervention
Secondary	Patient Health Questionnaire 9	Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better	12 months after intervention
Secondary	Generalized Anxiety Disorder 7	Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better	12 months after intervention
Secondary	Readiness to change questionnaire	Readiness to change questionnaire (RCQ), determines if the participant are in a precontemplation phase, contemplation phase or action phase	12 months after intervention